ZITHROMAX CAPSULES 250MG

The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 29 May 2019 SmPC

Reasons for updating

Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 April 2019 PIL

Reasons for updating

Change to section 4 - how to report a side effect

Change to section 6 - marketing authorisation holder

Change to section 6 - date of revision

Updated on 5 April 2019 SmPC

Reasons for updating

Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.8 DRESS frequency has been corrected from Very Rare to Rare

Updated on 25 October 2018 PIL

Reasons for updating

Change to section 6 - marketing authorisation holder

Change to section 6 - marketing authorisation number

Change to section 6 - date of revision

Updated on 25 October 2018 SmPC

Reasons for updating

Change to section 7 - Marketing authorisation holder

Change to section 8 - Marketing authorisation number(s)

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:Section 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 23 July 2018 SmPC

Reasons for updating

Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

4.6. Fertility, pregnancy and lactation

Subsection on breast-feeding updated in line with CDS.

Updated on 14 May 2018 SmPC

Reasons for updating

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

4.5. Interactions with other medicinal products and other forms of interaction

Inclusion of colchicine

Updated on 8 May 2018 PIL

Reasons for updating

Change to section 2 - interactions with other medicines, food or drink

Updated on 18 July 2017 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 18 July 2017 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.4 has been updated in line with the CDS

Updated on 14 July 2017 PIL

Reasons for updating

New PIL for new product

Updated on 14 July 2017 PIL

Reasons for updating

Change to section 4 - possible side effects

Change to section 6 - date of revision

Updated on 21 April 2017 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4 of the SmPC has been updated to include the addition of text regarding the increased incidence of infantile hypertrophic pyloric stenosis (IHPS) in neonates in connection with the use of Azithromycin.

Updated on 20 April 2017 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

Updated on 8 March 2016 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4 of the SmPC has been updated to include the addition of text regarding the increased incidence of infantile hypertrophic pyloric stenosis (IHPS) in neonates in connection with the use of Azithromycin.

Updated on 7 March 2016 PIL

Reasons for updating

Change to warnings or special precautions for use

Change to date of revision

Updated on 14 January 2016 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.8 of the SmPC has been updated to add the Adverse Drug Reaction ‘DRESS’ and consequentially the Section 4.4 of the SmPC has been updated to revise the text on hypersensitivity reactions.

Updated on 12 January 2016 PIL

Reasons for updating

Change of trade or active ingredient name

Change to warnings or special precautions for use

Change to storage instructions

Change to side-effects

Change to drug interactions

Change to further information section

Change to date of revision

Change to dosage and administration

Updated on 16 December 2014 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.6 - Pregnancy and lactation

Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

·Section 4.2 of the SmPC has been updated to add text relating to use in the elderly.

·Section 4.4 of the SmPC has been updated to revise the text on hypersensitivity, hepatotoxicity. Inaddition an enhanced precautionary text on prolongation of the QT interval has been added.

·Section 4.5 of the SmPC has been updated to add precautionary text for Digoxin and to add text for Atorvastin.

·Section 4.6 ofthe SmPC has been updated to add text pertaining to breast milk and fertility.

·Section 4.8 of the SmPC has been updated to add the Adverse Drug Reactions 'deafness', 'tinnitus and 'hearing impaired' to the Post-marketing subsection.

·Section 5.1 of the SmPC now includes updated text on microbiology information.

·Section 4.4 of the SmPC has been updated to draw attention to the possible fatal issue of QT prolongation

·Section 5.1 of the SmPC now includes updated text on cardiac electrophysiology with regards to co-administration of azithromycin and chloroquine.
To align with CSP

Updated on 9 December 2014 PIL

Reasons for updating

Change to warnings or special precautions for use

Change to side-effects

Change to drug interactions

Change to information about pregnancy or lactation

Change to further information section

Change to date of revision

Updated on 12 August 2014 PIL

Reasons for updating

Change to, or new use for medicine

Change to date of revision

Change to name of manufacturer

Updated on 25 June 2014 SmPC

Reasons for updating

Change to section 4.1 - Therapeutic indications

Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.1 and 4.2 of the SPC has been updated to include the indication gonococcal infection treatment and relevant dosing included in section 4.2.

Updated on 20 June 2014 PIL

Reasons for updating

Change to, or new use for medicine

Change to date of revision

Change to dosage and administration

Updated on 18 February 2013 SmPC

Reasons for updating

Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.1 – list of excipients - Addition of propylene glycol to the list of excipients for the capsule shell.

Updated on 14 February 2013 PIL

Reasons for updating

Change of inactive ingredient

Change to date of revision

Updated on 6 August 2012 SmPC

Reasons for updating

Change to section 6.5 - Nature and contents of container

Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section: 6.5. - Nature and contents of container

Section 6.6. - Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Updated on 26 July 2011 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.3 - Contraindications

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

﻿Changes to Sections: 4.2, 4.3, 4.4, 4.5 and 4.8

Updated on 22 July 2011 PIL

Reasons for updating

Change to warnings or special precautions for use

Change of contraindications

Change to side-effects

Change to drug interactions

Change to date of revision

Updated on 5 February 2010 PIL

Reasons for updating

Change due to user-testing of patient information

Updated on 3 November 2008 PIL

Reasons for updating

Change to warnings or special precautions for use

Change to side-effects

Updated on 31 October 2008 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 Special Warnings and Precautions for Use and 4.8 Undesirable effects of the SPC to align with the company core data sheet: Clostridium difficile associated diarrhoea, caution warning for diabetic patients, addition of Hypoesthesia to side effects.

Updated on 3 October 2007 SmPC

Reasons for updating

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.5

Spelling of Cyclosporim has changed to Ciclosporim

Updated on 27 September 2007 PIL

Reasons for updating

Change of special precautions for disposal

Updated on 30 July 2007 PIL

Reasons for updating

Change of trade or active ingredient name

Change to storage instructions

Change to date of revision

Change from the BAN of the active substance to the rINN

Updated on 27 July 2007 SmPC

Reasons for updating

Change to section 1 - Name of medicinal product

Change to section 2 - Qualitative and quantitative composition

Change to section 3 - Pharmaceutical form

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 6.1 - List of excipients

Change to section 6.2 - Incompatibilities

Change to section 6.3 - Shelf life

Change to section 6.6 - Special precautions for disposal and other handling

Change to section 9 - Date of renewal of authorisation

Change to section 4.4 - Special warnings and precautions for use

Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Zithromax Capsules 250mg:

Section 1 Reformatting of medicinal product name

Section 2 Inclusion of lactose content

Section 3 More detailed description of pharmaceutical form as ‘Capsule, hard’

Section 4.5 Amend ‘Cyclosporine’ to ‘Cyclosporin’

Section 6.1 Reformatting of text for excipients

Section 6.2 Replacement of text from ‘none known’ to ‘not applicable’

Section 6.3 Reformatting of text for shelf-life from duration in months to years.

Section 6.6 Update section heading in line with QRD template = Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product; also amended special precautions for disposal and handling amended to ‘no special requirements’

Section 9 Updated renewal date

Zithromax Powder for Oral Suspension 200mg/5ml

Section 1 Reformatting of medicinal product name

Section 2 Inclusion of sucrose content

Section 4.4 Typographical error amended (‘ketokide’ to ‘ketolide’)

Section 4.5 Amend ‘Cyclosporine’ to ‘Cyclosporin’

Section 6.1 Reformatting of text for excipients

Section 6.2 Replacement of text from ‘none known’ to ‘not applicable’

Section 6.5 Deletion of text detailing age and weight recommendations in nature and contents of container

Section 6.6 Update heading according in line with QRD template = Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Section 9 Updated renewal date

Updated on 26 October 2006 PIL

Reasons for updating

Change to warnings or special precautions for use

Change to dosage and administration

Change to side-effects

Change to further information section

Updated on 25 October 2006 SmPC

Reasons for updating

Change to section 4.1 - Therapeutic indications

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.2 - Posology and method of administration

Change to section 4.3 - Contraindications

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.6 - Pregnancy and lactation

Change to section 4.8 - Undesirable effects

Change to section 5.1 - Pharmacodynamic properties

Change to section 5.2 - Pharmacokinetic properties

Change to section 5.3 - Preclinical safety data

Change to section 6.2 - Incompatibilities

Change to section 6.5 - Nature and contents of container

Change to section 6.6 - Special precautions for disposal and other handling

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.1 and 4.4 - revised in line with Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections